Curetis N.V. (the "Company" and together with its subsidiaries" Curetis"), a developer of next-level molecular diagnostic solutions, today announced the U.S. commercial launch of its Unyvero sample-to-answer molecular diagnostic system and the Unyvero LRT Application Cartridge for lower respiratory tract infections at the ASM Microbe 2018 Congress in Atlanta, GA, USA (June 7-11). Curetis obtained regulatory clearance for the Unyvero System and Unyvero LRT from the U.S. FDA in April this year.

The Unyvero System, together with the Unyvero LRT Application Cartridge, provides rapid infectious disease testing directly from aspirate samples in less than five hours. It covers more than 90% of infection cases of hospitalized pneumonia patients and provides clinicians with a comprehensive overview of genetic antibiotic resistance markers detected. As the first-in-class molecular test for lower respiratory tract infections with no direct molecular diagnostic competition, it addresses a significant unmet medical need that causes over $10bn in annual costs for the U.S. healthcare system (see references 1, 2 below). It is also the first time that the U.S. FDA has granted clearance for an automated molecular diagnostic test for the atypical microorganism Legionella pneumoniae.

The potential of the Unyvero System and LRT Application Cartridge to positively impact clinical outcomes, support antibiotic stewardship, and create health economic benefits is substantiated by several key contributions to the scientific program of ASM Microbe 2018:

Dr. Chiagozie I. Pickens, MD, and colleagues from the Northwestern Memorial Hospital, Chicago, IL, USA show data demonstrating that delays in the transport time of LRT specimens to the microbiology laboratory result in loss of viable pathogens, including virulent nosocomial pathogens. They conclude that “molecular technologies, such as Unyvero PCR, are less affected and identified causative agents even after long transport times.”

Dr. Matthew D. Sims, MD, PhD, and his group at William Beaumont Hospital, Royal Oak, MI, USA, evaluated Unyvero LRT with regard to clinical impact and antibiotic stewardship and conclude that “the Unyvero Platform and the LRT Cartridge have significant potential to improve the management of lower respiratory tract infections and can improve antibiotic stewardship at the same time.” This poster is also featured in an oral presentation by Dr. Sims during the Lounge & Learn Session “Outcomes Impacting Income: Cost Effective Clinical Diagnostics.”

In addition, in an Industry and Science Workshop hosted by Curetis USA, Dr. Joseph M. Campos, PhD, D(ABMM), F(AAM), Director of Microbiology Laboratory, Infectious Disease Molecular Diagnostics Laboratory, and Laboratory Informatics at Children’s National Medical Center, Washington, DC, USA, will share early results from the evaluation of the Unyvero System and the Unyvero LRT Application at his institution.

“ASM Microbe is an ideal platform to launch the Unyvero System and the LRT Application Cartridge in the U.S.,” commented Chris Bernard, President and CEO of Curetis USA Inc. and EVP Global Sales.“ The advantages of Unyvero, highlighted by Dr. Pickens and Dr. Sims in the congress’ scientific program, are also recognized by many clinicians and laboratory directors at those hospitals we have been actively reaching out to following the FDA clearance decision. We are making very good progress in getting Unyvero Systems installed in several of those accounts short-term and expect to have signed multiple commercial evaluation agreements in the coming weeks. We also received the first commercial Unyvero cartridge order from a U.S. customer.”

To drive the commercial roll-out of the Unyvero System and Unyvero LRT as a first application cartridge in the U.S., the Company has completed the U.S. commercial operations setup and has a dedicated team of about 25 seasoned commercialization experts at its Curetis USA Inc. subsidiary in San Diego, CA. With the commercial team in place and the roll-out initiated, Curetis is targeting the placement of 40 to 50 Unyvero Analyzers by year-end 2018 and 60 to 80 Analyzers within the first full year of commercial availability in the U.S.

References
(1) CDC (2015) ‘New CDC study highlights burden of pneumonia hospitalizations among US adults’, available at: https://www.cdc.gov/media/releases/2015/p0714-pneumonia-hospitalizations.html
(2) American Thoracic Society (2015) ‘Top 20 pneumonia facts – 2015’, available at: https://www.thoracic.org/patients/patient-resources/resources/top-pneumonia-facts.pdf